510(k) · Cleared
Recalled · 2011Newdeal Hallu Lock Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newdeal Sas · HRS Plate, Fixation, Bone
Cleared on Jul 10, 2009 as substantially equivalent to K021626 (New Deal, S.A., 2002) after a 259-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2009
- Review
- 259 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000684 (2000). 11 ancestors in all, the oldest K890939 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 2 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 1 generation backK021626 Hallu PlatesNew Deal, S.A. · 2002
- This deviceK083154 Newdeal Hallu Lock Plate SystemNewdeal Sas · 2009
- Descendant · cites it directly · 1 of its ownK093781 Modified: Newdeal Hallu PlatesNewdeal Sas · 2010
- Descendant · cites it directly · 0 of its ownK210016 Integra DigiFuse Cannulated Intramedullary Fusion System,Integra…Integra LifeSciences Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −2 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −1 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| 0 (this device) | K083154 | Newdeal Hallu Lock Plate System | Newdeal Sas | 2009 | — |
| +1 | K093781 | Modified: Newdeal Hallu Plates | Newdeal Sas | 2010 | — |
| +1 | K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot… | Integra LifeSciences Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021626 | Hallu PlatesSummary page 2…e 1 of 2 Substantial Equivalence: The modified HALLU® Lock Plate System is substantially equivalent to commercially marketed device, HALLU® Plate System, K021626 Device Description: The Newdeal HALLU® Lock Plate System is a low profile Titanium plate dedicated to first metatarso-phalange… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2011 | Not classified | Z-1147-2012 | Error in labeling | Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K093781 (Newdeal Sas, 2010) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K021626.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The HALLU® Lock Plates are intended for fixation of fractures, osteotomies or
arthrodesis of the first metatarso-phalangeal joint. Including cases of:
- Hallux rigidus
- Severe hallux valgus (IM angle >200 and HV angle >400)
- Deformity from rheumatoid arthritis
- Failed previous surgical procedure
- Traumatic arthritis
- Neuromuscular instability.
The HALLU® Lock plates must be fixed with the SURFIX ® fixed angle locking system
and with the SURFIX®-Alpha variable angle locking system of 2.7mm or 3.0mm
diameter (screws and lock-screws).
Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for
optimal arthrodesis consolidation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083154: Newdeal Hallu Lock Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026